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12 Month Open Extension of TNS for ADHD.

NCT03888391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-05-29

Study results available
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Summary

Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

DEVICE

Active TNS

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • James McGough

    lead OTHER

Principal Investigators

  • James J. McGough, M.D. · University of California, Los Angelesr

  • Sandra K. Loo, Ph.D. · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-01
Primary Completion
2018-05-30
Completion
2018-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03888391 on ClinicalTrials.gov